Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds
A Comparison of the Immunogenicity and Descriptive Safety of a Live Attenuated Herpes Zoster Vaccine and the Glaxo Smith Kline (GSK) Herpes Zoster Recombinant HZ/su Candidate Vaccine in 50-59 Year Old and 70-85 Year Old Vaccine Recipients
1 other identifier
interventional
160
1 country
1
Brief Summary
This study will compare the two vaccines that have been developed to prevent and/or lessen the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other, herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an ingredient that may enhance the body's immune response to the vaccine, and is currently investigational. The vaccines are being compared to assess their ability to stimulated protection against shingles. The study will provide an opportunity to determine the safety profile of each vaccine in a single trial. The study will also look at the effect of age on the immune response to the two vaccines and on the persistence of these responses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2014
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2014
CompletedFirst Posted
Study publicly available on registry
April 15, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedJuly 8, 2020
July 1, 2020
1.8 years
April 11, 2014
July 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number
Measured up to Day 730
Secondary Outcomes (1)
Changes in glycoprotein-based enzyme-linked immunosorbent assay (gpELISA)
Measured up to Day 730
Other Outcomes (1)
Evaluation of Unsolicited adverse events
Within 30 days of each vaccination
Study Arms (4)
A - Live zoster vaccine
ACTIVE COMPARATORNo previous zoster vaccine; stratified between age groups 50-59 and 70-85 First dose live vaccine, Zostavax (0.65ml, subcutaneous) Second dose placebo, normal saline (0.65ml. subcutaneous)
B - recombinant zoster vaccine
ACTIVE COMPARATORNo previous zoster vaccine; stratified between age groups 50-59 and 70-85 First dose recombinant vaccine, HZ/su (0.5ml, intramuscular) Second dose recombinant vaccine, HZ/su (0.5ml, intramuscular)
C - Live zoster vaccine
ACTIVE COMPARATOROne previous dose of zoster vaccine at least 5 years previously, age 70-85 First dose live vaccine, Zostavax (0.65ml, subcutaneous) Second dose placebo, normal saline (0.65ml. subcutaneous)
D - recombinant zoster vaccine
ACTIVE COMPARATOROne previous dose of zoster vaccine at least 5 years previously, age 70-85 First dose recombinant vaccine, HZ/su (0.5ml, intramuscular) Second dose recombinant vaccine, HZ/su (0.5ml, intramuscular)
Interventions
0.5ml, intramuscular
0.65ml, subcutaneous
Eligibility Criteria
You may qualify if:
- History of varicella or residence int he US for 30 years
- For Arms C and D - prior live zoster vaccine at least 5 years previously
- For Arms A and B - Age 50-59 or 70-85
- For Arms C and D - Age 70-85
- For women of childbearing potential, a negative pregnancy test and agreement to use adequate contraception from 30 days before until 3 months after the last dose of any study vaccine
You may not qualify if:
- History of herpes zoster
- For Arms A and B - prior live zoster vaccine
- Immune compromising illness or therapies or chronic illness
- Allergy to previous herpes zoster vaccine
- Other investigational drugs or vaccines within the past 6 months before the study and until last visit
- Blood products for 3 months prior to or planned during the study
- Concomitant non-topical antiviral therapy within 3 days prior to and 7 days after vaccination.
- Vaccines within 2 weeks (inactive vaccine) or 4 weeks (live vaccine) prior to the study until 30 days after any dose of either vaccine.
- Pregnancy or breast-feeding
- Current drug addiction or alcoholism.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- GlaxoSmithKlinecollaborator
Study Sites (1)
Pediatric Infectious Diseases and Clinical Trials, Universtiy of Colorado School of Medicine
Aurora, Colorado, 80045, United States
Related Publications (2)
Johnson MJ, Liu C, Ghosh D, Lang N, Levin MJ, Weinberg A. Cell-Mediated Immune Responses After Administration of the Live or the Recombinant Zoster Vaccine: 5-Year Persistence. J Infect Dis. 2022 Apr 19;225(8):1477-1481. doi: 10.1093/infdis/jiab580.
PMID: 34850039DERIVEDWeinberg A, Kroehl ME, Johnson MJ, Hammes A, Reinhold D, Lang N, Levin MJ. Comparative Immune Responses to Licensed Herpes Zoster Vaccines. J Infect Dis. 2018 Sep 22;218(suppl_2):S81-S87. doi: 10.1093/infdis/jiy383.
PMID: 30247596DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myron J Levin, M.D.
University of Colorado School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2014
First Posted
April 15, 2014
Study Start
May 1, 2014
Primary Completion
March 1, 2016
Study Completion
May 1, 2020
Last Updated
July 8, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share